UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma(JCOG0110, GCSSG-SPNX)
Title of the study (Brief title)	Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma(JCOG0110, GCSSG-SPNX)
Region	Japan

Condition
Condition	T2, T3, and T4 carcinoma in the proximal third of the stomach
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	overall survival
Key secondary outcomes	relapse-free survival, post-operative morbidity, operation time and perioperative blood loss

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A:Surgery:splenectomy
Interventions/Control_2	B:Surgery:spleen-preservation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Preoperatively, (1) histologically proven adenocarcinoma (2)T2 or deeper lesion in the upper third of the stomach without involvement of the greater curvature or esophageal invasion more than 3 cm, irrespective of the primary tumor location or existence of multiple foci (3) no distant metastasis, not linitis plastica ('Borrmann 4'), not stump carcinoma, no prior treatment for 364 Randomized trial for splenectomy gastric cancer (4) sufficient organ function (5) written informed consent. Intra-operatively, (6) T2/T3/T4 and N0/N1/N2, no tumor on the greater curvature, no direct invasion of the pancreas or spleen, negative peritoneal lavage cytology (7) no apparent nodal metastasis in the splenic hilum or along the splenic artery
Key exclusion criteria	(1) Liver cirrhosis or portal hypertension (2) idiopathic thrombocytopenic purpura (3) severe pulmonary dysfunction (4)synchronous or metachronous (within 5 years) malignancy
Target sample size	500

Research contact person
Name of lead principal investigator	Mitsuru Sasako, MD, PhD
Organization	Hyogo College of Medicine
Division name	Upper GI Surgery Division
Address	1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6767
Email	msasako@hyo-med.ac.jp

Public contact
Name of contact person	Takeshi Sano, MD, PhD
Organization	JCOG0110 Coordinating Office
Division name	Gastroenterological Surgery, Cancer Institute Hospital
Address	3-10-6, Ariake, Koto-ku, Tokyo, 135-8550, JAPAN
TEL	03-3520-0111
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT00112099
Org. issuing International ID_1	ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

函館厚生院函館五稜郭病院（北海道） 岩手医科大学（岩手県） 国立病院機構仙台医療センター（宮城県） 宮城県立がんセンター（宮城県） 山形県立中央病院（山形県） 防衛医科大学校（埼玉県） 埼玉県立がんセンター（埼玉県） 国立がん研究センター東病院（千葉県） 国立がん研究センター中央病院（東京都） がん・感染症センター都立駒込病院（東京都） 東京医科歯科大学（東京都） がん研究会有明病院（東京都） 都立墨東病院（東京都） 神奈川県立病院機構神奈川県立がんセンター（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 新潟県厚生連長岡中央綜合病院（新潟県） 燕労災病院（新潟県） 富山県立中央病院（富山県） 岐阜市民病院（岐阜県） 静岡県立総合病院（静岡県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 国立病院機構京都医療センター（京都府） 大阪大学医学部（大阪府） 近畿大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 国立病院機構大阪医療センター（大阪府） 大阪医科大学（大阪府） 市立豊中病院（大阪府） 市立堺病院（大阪府） 兵庫医科大学（兵庫県） 兵庫県立がんセンター（兵庫県） 市立伊丹病院（兵庫県） 和歌山県立医科大学（和歌山県） 広島市立広島市民病院（広島県） 広島市立安佐市民病院（広島県） 国立病院機構四国がんセンター（愛媛県） 大分大学医学部附属病院（大分県）

Other administrative information
Date of disclosure of the study information	2005 Year 06 Month 07 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2002 Year 04 Month 04 Day
Anticipated trial start date	2002 Year 06 Month 01 Day
Last follow-up date	2014 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27280511
Results	See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
Other related information	Jpn J Clin Oncol 2002; 32(9) 363-364

Management information
Registered date	2005 Year 06 Month 06 Day
Last modified on	2017 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000018